Trial Outcomes & Findings for Olaparib for the Treatment of Castration Resistant Prostate Adenocarcinoma (NCT NCT04951492)

NCT ID: NCT04951492

Last Updated: 2025-01-01

Results Overview

The proportion of patients achieving at least a 50% decline in PSA from baseline will be presented.

• Recruitment status: TERMINATED
• Study phase: PHASE2
• Target enrollment: 2 participants
• Primary outcome timeframe: At least 12 weeks of olaparib treatment
• Results posted on: 2025-01-01

Participant Flow

Participant milestones

Measure	Treatment (Olaparib) Patients receive olaparib orally (PO) twice daily (BID). Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. Olaparib: Given PO
Overall Study STARTED	2
Overall Study COMPLETED	2
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Olaparib for the Treatment of Castration Resistant Prostate Adenocarcinoma

Baseline characteristics by cohort

Measure	Treatment (Olaparib) n=2 Participants Patients receive olaparib orally (PO) twice daily (BID). Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. Olaparib: Given PO
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	0 Participants n=5 Participants
Age, Categorical >=65 years	2 Participants n=5 Participants
Sex: Female, Male Female	0 Participants n=5 Participants
Sex: Female, Male Male	2 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	2 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants
Race (NIH/OMB) White	2 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Region of Enrollment United States	2 participants n=5 Participants

PRIMARY outcome

Timeframe: At least 12 weeks of olaparib treatment

Population: Patients who received at least 12 weeks of olaparib

The proportion of patients achieving at least a 50% decline in PSA from baseline will be presented.

Outcome measures

Measure	Treatment (Olaparib) n=1 Participants Patients receive olaparib orally (PO) twice daily (BID). Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. Olaparib: Given PO
Lowest On-treatment Prostate Specific Antigen (PSA)	0 participants

SECONDARY outcome

Timeframe: Up to 12.3 weeks

Will be defined as the proportion of participants demonstrating at least a 30% decrease in total tumor size from baseline per Response Evaluation Criteria in Solid Tumors 1.1 criteria at any time point. The percent of patients with ORR and range of values will be provided.

Outcome measures

Measure	Treatment (Olaparib) n=2 Participants Patients receive olaparib orally (PO) twice daily (BID). Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. Olaparib: Given PO
Overall Response Rate (ORR)	0 Participants

SECONDARY outcome

Timeframe: Up to 12.3 weeks

Radiographic progression will be determined as using RECIST v1.1 and/or PCWG3 criteria. Median PFS will be estimated using the Kaplan-Meier method.

Outcome measures

Measure	Treatment (Olaparib) n=2 Participants Patients receive olaparib orally (PO) twice daily (BID). Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. Olaparib: Given PO
Radiographic Progression Free Survival (PFS)	12.3 weeks Interval 11.0 to 12.3

SECONDARY outcome

Timeframe: Up to 16.6 weeks

PSA progression will be time to for the PSA to increase by at least 2 ng/ml and ≥20% above baseline. PSA PFS will be the time until PSA progression and will be analyzed using kaplan meier method, with the median PSA PFS reported

Outcome measures

Measure	Treatment (Olaparib) n=2 Participants Patients receive olaparib orally (PO) twice daily (BID). Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. Olaparib: Given PO
Prostate Specific Antigen (PSA) Progression Free Survival (PFS)	12 weeks Interval 12.0 to 16.6

SECONDARY outcome

Timeframe: Up to 12.3 weeks

Number of patients who died on study. Note: Plan was to assess time from enrollment to death; however, no deaths have been observed.

Outcome measures

Measure	Treatment (Olaparib) n=2 Participants Patients receive olaparib orally (PO) twice daily (BID). Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. Olaparib: Given PO
Overall Survival	0 Participants

Adverse Events

Treatment (Olaparib)

Serious events: 1 serious events

Other events: 2 other events

Deaths: 0 deaths

Serious adverse events

Measure	Treatment (Olaparib) n=2 participants at risk Patients receive olaparib orally (PO) twice daily (BID). Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. Olaparib: Given PO
Vascular disorders Pulmonary Embolism	50.0% 1/2 • Number of events 1 • Within 30 days of end of treatment, up to 16.6 weeks

Other adverse events

Measure	Treatment (Olaparib) n=2 participants at risk Patients receive olaparib orally (PO) twice daily (BID). Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. Olaparib: Given PO
Gastrointestinal disorders Nausea	100.0% 2/2 • Number of events 2 • Within 30 days of end of treatment, up to 16.6 weeks
General disorders Fatigue	100.0% 2/2 • Number of events 2 • Within 30 days of end of treatment, up to 16.6 weeks
Metabolism and nutrition disorders Anorexia	50.0% 1/2 • Number of events 1 • Within 30 days of end of treatment, up to 16.6 weeks
Gastrointestinal disorders Diarrhea	50.0% 1/2 • Number of events 1 • Within 30 days of end of treatment, up to 16.6 weeks
Blood and lymphatic system disorders Anemia	100.0% 2/2 • Number of events 2 • Within 30 days of end of treatment, up to 16.6 weeks
Musculoskeletal and connective tissue disorders Myalgia	50.0% 1/2 • Number of events 1 • Within 30 days of end of treatment, up to 16.6 weeks
Musculoskeletal and connective tissue disorders Bone Pain	50.0% 1/2 • Number of events 1 • Within 30 days of end of treatment, up to 16.6 weeks
Injury, poisoning and procedural complications Left Forearm Tear	50.0% 1/2 • Number of events 1 • Within 30 days of end of treatment, up to 16.6 weeks
Respiratory, thoracic and mediastinal disorders Cough	50.0% 1/2 • Number of events 1 • Within 30 days of end of treatment, up to 16.6 weeks
Nervous system disorders Dysgeusia	50.0% 1/2 • Number of events 1 • Within 30 days of end of treatment, up to 16.6 weeks
Nervous system disorders Lightheadedness	50.0% 1/2 • Number of events 1 • Within 30 days of end of treatment, up to 16.6 weeks
Investigations White Blood Cell Count Decreased	50.0% 1/2 • Number of events 1 • Within 30 days of end of treatment, up to 16.6 weeks
Investigations Neutrophil Count Decreased	50.0% 1/2 • Number of events 1 • Within 30 days of end of treatment, up to 16.6 weeks
Cardiac disorders Supraventricular Tachycardia	50.0% 1/2 • Number of events 1 • Within 30 days of end of treatment, up to 16.6 weeks
Investigations Lymphocyte Count Decreased	100.0% 2/2 • Number of events 2 • Within 30 days of end of treatment, up to 16.6 weeks

Additional Information

Dr. Michael Schweizer

Fred Hutchinson Cancer Center

Phone: 2066066252

Email: mtschwei@fredhutch.org

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place